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Feasibility of Adherence to Light Therapy

Primary Purpose

Major Depression in Remission

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Light therapy

About this trial

This is an interventional prevention trial for Major Depression in Remission focused on measuring major depressive disorder, light therapy, relapse prevention, adherence

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

[1] Outpatients 19 to 65 years of age;
[2] DSM-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
[3] taking an antidepressant for no more than six months;
[4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
[5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS];
[6] Willing and able to complete self-report and online assessments including sufficient fluency in English.

Exclusion Criteria:

[1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
[2] MDD with psychotic features (lifetime);
[3] significant personality disorder diagnosis [e.g., borderline, antisocial];
[4] High suicidal risk, defined by clinician judgment;
[5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;
[6] Significant neurological disorders, head trauma, or other unstable medical conditions;
[7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);
[8] history of severe withdrawal effects with antidepressant discontinuation;
[9] retinal disease or other eye condition preventing use of bright light therapy;
[10] use of photosensitizing medication within 1 week of baseline visit.

Sites / Locations

UBC Mood Disorders CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Light therapy

Arm Description

Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.

Outcomes

Primary Outcome Measures

Adherence

Rate of adherence (>75% of total daily sessions) to light therapy

Secondary Outcome Measures

Relapse rate

Relapse will be defined as any of the following: [1] MADRS total score ≥22 for at least 2 consecutive weeks. If the relapse criterion of MADRS total score ≥22 is met at a scheduled assessment visit or an unscheduled relapse-assessment visit, an additional visit (i.e., the relapse-verification visit) will be scheduled within 1 to 2 weeks to verify the relapse; [2] Hospitalization for worsening of depression; [3] Suicidal ideation with intent, or suicidal behavior; [4] Any change in treatment (e.g., starting an antidepressant).

Change in clinician-rated depressive symptoms

Changes in scores from baseline to 12 weeks on the Montgomery-Asberg Depression Rating Scale.

Change in patient-rated depressive symptoms

Changes in scores from baseline to 12 weeks on the Quick Inventory of Depressive Symptomatology, Self-Rated scale.

Discontinuation symptoms

Scores on a discontinuation effects scale developed for this study.

Full Information

NCT ID

NCT04944758

First Posted

June 14, 2021

Last Updated

September 28, 2021

Sponsor

University of British Columbia

Collaborators

Michael Smith Foundation for Health Research

1. Study Identification

Unique Protocol Identification Number

NCT04944758

Brief Title

Feasibility of Adherence to Light Therapy

Official Title

A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

Collaborators

Michael Smith Foundation for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.

Detailed Description

Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment. Light therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question. Before conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression in Remission

Keywords

major depressive disorder, light therapy, relapse prevention, adherence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open-label feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Light therapy

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Light therapy

Intervention Description

Light therapy

Primary Outcome Measure Information:

Title

Adherence

Description

Rate of adherence (>75% of total daily sessions) to light therapy

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Relapse rate

Description

Time Frame

12 weeks

Title

Change in clinician-rated depressive symptoms

Description

Changes in scores from baseline to 12 weeks on the Montgomery-Asberg Depression Rating Scale.

Time Frame

12 weeks

Title

Change in patient-rated depressive symptoms

Description

Changes in scores from baseline to 12 weeks on the Quick Inventory of Depressive Symptomatology, Self-Rated scale.

Time Frame

12 weeks

Title

Discontinuation symptoms

Description

Scores on a discontinuation effects scale developed for this study.

Time Frame

4, 8, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: [1] Outpatients 19 to 65 years of age; [2] DSM-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview; [3] taking an antidepressant for no more than six months; [4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons; [5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS]; [6] Willing and able to complete self-report and online assessments including sufficient fluency in English. Exclusion Criteria: [1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime); [2] MDD with psychotic features (lifetime); [3] significant personality disorder diagnosis [e.g., borderline, antisocial]; [4] High suicidal risk, defined by clinician judgment; [5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening; [6] Significant neurological disorders, head trauma, or other unstable medical conditions; [7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers); [8] history of severe withdrawal effects with antidepressant discontinuation; [9] retinal disease or other eye condition preventing use of bright light therapy; [10] use of photosensitizing medication within 1 week of baseline visit.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Research Coordinator

Phone

604-822-8012

samantha.huang@ubc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Research Coordinator

Phone

604-822-8012

vanessa.evans@ubc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond W Lam, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

UBC Mood Disorders Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T1Z3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vanessa Evans

Phone

604-822-8012

vanessa.evans@ubc.ca

First Name & Middle Initial & Last Name & Degree

Trisha Chakrabarty, MD

First Name & Middle Initial & Last Name & Degree

Kam Keramatian, MD

First Name & Middle Initial & Last Name & Degree

Edwin Tam, MDCM

First Name & Middle Initial & Last Name & Degree

Andre Do, MDCM

12. IPD Sharing Statement

Plan to Share IPD

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Feasibility of Adherence to Light Therapy

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